Legal requirements for the quality of herbal substances and herbal preparations for the manufacturing of herbal medicinal products in the European union.

In the European Union (EU) herbal medicinal products have become increasingly important. This is, for instance, underlined by the recent introduction of a simplified procedure in the Member States of the EU allowing the registration of herbal medicinal products which fulfill the criteria of a traditional herbal medicinal product, i.e., sufficient evidence of its medicinal use throughout a period of at least 30 years for products in the EU and at least 15 years within the EU and 15 years elsewhere for products outside the EU. With regard to the manufacturing of these products and their quality, applications of traditional herbal medicinal products have to fulfil the same requirements as applications for a marketing authorization. The quality of herbal substances as well as herbal preparations will be determined by the availability of modern science-based public monographs in the European Pharmacopoeia and their equivalents developed by the pharmaceutical industry. The standards put forward in these monographs must allow us not only to define the quality of these products, but also to eliminate dangerous counterfeit, substandard, adulterated and contaminated (traditional) herbal medicinal products. The usefulness of these monographs to implement the criteria on quality and specifications put forward for these products in the different guidelines of the European Medicines Agency (EMEA) is discussed.

[Folk and nontraditional medicine in the health care system in the world].

The data about contribution of folk and nontraditional medicine technologies into the system of medical aid rendering of countries of all regions of the world are presented in the article.

Intellectual property protection in the natural product drug discovery, traditional herbal medicine and herbal medicinal products.

Traditional medicine is an important part of human health care in many developing countries and also in developed countries, increasing their commercial value. Although the use of medicinal plants in therapy has been known for centuries in all parts of the world, the demand for herbal medicines has grown dramatically in recent years. The world market for such medicines has reached US $ 60 billion, with annual growth rates of between 5% and 15%. Researchers or companies may also claim intellectual property rights over biological resources and/or traditional knowledge, after slightly modifying them. The fast growth of patent applications related to herbal medicine shows this trend clearly. This review presents the patent applications in the field of natural products, traditional herbal medicine and herbal medicinal products. Medicinal plants and related plant products are important targets of patent claims since they have become of great interest to the international drug and cosmetic industry.

Changes in the traditional Korean medical sector as a result of health related legislation.

The objective of this study is to determine the effect of changes in the legal systems related to traditional Korean medicine (TKM) and their effect on health care in Korea. To cope with the many changes and challenges in the Korean health care system, health law has been used as an instrument to implement national health policies and support the developments of health systems. In particular, the Medical Service Act, amended in 1951, was the key factor for the coexistence of TKM and Western medicine in Korea. For systematizing the TKM, the roles of the National Health Insurance Act and the Medical Service Act were crucial. Considering Korea's experiences, health laws related to TKM were designed to regulate the health care system and have contributed to improve the quality and safety of TKM.